In an increasingly lucrative market, dozens of companies and startups are selling futuristic-looking headgear that promise to connect to your brain to relieve stress, enhance memory, improve sleep or increase focus.
But, but, but: Experts suggest these products make mostly unsubstantiated claims and in some cases can harm unwary buyers.
"There's a bit of pulling the wool over people's eyes, trying to talk up these products in a way that isn't sincere and transparent," says Karola Kreitmair, a medical ethics expert at the University of Wisconsin.
What's happening: There are two broad categories of wearable brain devices — those that record the user’s brain activity and others that stimulate the brain with electrical currents. These technologies are mainstays in research labs and hospitals — but now they're on Amazon and Kickstarter, too.
- Bellabee, a $159 headband and app, says it can help reduce symptoms of ADHD and PTSD.
- Modius, a $499 headset, claims to curb the appetite and help users lose weight.
- The Brain Stimulator, a $120 device with electrodes that send a current to the brain, says it's based on technology that can help with depression, pain, addiction and memory.
None of the three — a small subset of the growing market — offers research showing that their specific devices do what they claim. None responded to requests for comment.
The big picture: Many companies are imbuing products with an air of medical legitimacy without pointing to serious research. A common pattern: Companies say their products are based ontechnology that has been shown to be beneficial in some way — but provide no research on their products.
- A study published in Neuron found 41 "neurotechnology" products currently for sale that target either the general public or some particularly vulnerable subset — like children, the elderly, or people with a medical condition.
- Only 33 provided any supporting research, the study found. And just 8 referred to relevant peer-reviewed research.
- Most of the rest made claims about a general technology, or leaned on user testimonials and in-house research that wasn't reviewed by outsiders.
Customers who buy an ineffective device could be in for more than a disappointing waste of money.
- Transcranial direct current stimulation (tDCS), which involves administering a weak electric current to the head, has been tested in labs for depression and anxiety, but the effects of overuse aren't well understood. The method can also cause skin burns and headaches.
- And consumer EEG devices, which record brain activity, can influence user behavior by reinforcing certain "brain states." Scientists question both the accuracy of the device readings, and the scientific basis of drawing any conclusions from them.
The government has done little to police companies selling these devices straight to consumers. "This is a case where industry has run away with something because people are willing to pay money for it — but regulation and validation completely lags behind," Kreitmair, the University of Wisconsin professor, tells Axios.
- Because of how quickly these devices are being developed, the FDA, which regulates medical devices, and the FTC, which protects consumers from false advertising, are ill prepared to reign in companies, says Anna Wexler, a University of Pennsylvania medical ethicist.
- Wexler has proposed convening researchers and industry experts to monitor direct-to-consumer products and work with regulators.
- Other ethics experts — like Judy Illes of the University of British Columbia, a co-author of the Neuron study — say the fledgling industry needs to be pressured to self-regulate.
An FDA spokesperson said the agency doesn't discuss potential investigations, but that the agency has in the past increased scrutiny of certain devices "when necessary to protect patients.